Effects of Pioglitazone on Heart Failure in Obese Type 2 Diabetics
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
This study is testing if the diabetes drug Pioglitazone can help improve heart function in obese people with type 2 diabetes and heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05838287 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the diabetes medication Pioglitazone on heart function in obese participants with type 2 diabetes and heart failure with preserved ejection fraction (HFpEF). Participants will be randomized to receive either Pioglitazone or a placebo, and various measures such as myocardial blood flow, insulin sensitivity, and heart function will be assessed. The study aims to demonstrate that Pioglitazone can improve heart function by enhancing insulin sensitivity and reducing fat content in the heart. The research will also explore the role of mitochondrial function in the development of HFpEF in this population.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 30-70 with type 2 diabetes and heart failure with preserved ejection fraction.
Not a fit: Patients with heart failure not classified as NYHA class II-III or those with contraindications to Pioglitazone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to improve heart function in obese patients with type 2 diabetes and heart failure.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific application of Pioglitazone in this population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30-70 years 4. Body Mass Index (BMI) of 27.5-40kg/m² 5. HbA1c of 6.5 to 10% 6. Blood pressure of less than or equal to 145/65mmHg 7. eGFR greater than 45 ml/min/1.73m² 8. Subject must have HFpEF (EF \> 50% by ECHO screening) 9. NYHA class II-III heart failure 10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied. 11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation. 12. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: 1. Subjects with history of osteoporosis or proliferative diabetic retinopathy 2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded 3. Patients with symptomatic coronary artery disease. 4. Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication). 5. Subjects treated with a GLP-1 RA or thiazolidinedione. 6. Subjects treated with a SGLT2i 7. Pregnancy or lactation 8. Known allergic reactions to components of the study interventions. 9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
Where this trial is running
San Antonio, Texas
- Texas Diabetes Institute/UH — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ralph A DeFronzo, MD — University of Texas
- Study coordinator: Sivaram Neppala, MD
- Email: neppalas@uthscsa.edu
- Phone: 210-358-7200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.